Ambulatory infusion pumps and assemblies for use with same

ABSTRACT

Ambulatory infusion pumps, medicament reservoirs, and medicament sealing assemblies, including a variety of trocar seal assemblies and fill plug seal assemblies, plus related components, as well as component combinations and related methods.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to previously filedU.S. Provisional Patent Application Ser. No. 62/294,941, filed Feb. 12,2016, which is incorporated herein by reference in its entirety.

BACKGROUND 1. Field

The present devices and methods relate generally to ambulatory infusionpumps and seals for those pumps.

2. Description of the Related Art

Ambulatory infusion pumps (also referred to herein simply as “infusionpumps”) are relatively small, at least substantially self-containeddevices that are used to introduce drugs and other infusible substances(collectively “medicament”) into patients' bodies. Some infusion pumpsare configured to be worn on a belt, carried in a clothing pocket, orthe like. Other infusion pumps are configured to be adhered to skin inpatch-like fashion. Infusion pumps are advantageous in that they may beused to, for example, subcutaneously introduce (or “infuse”) medicamenton an ongoing or even continuous basis outside of a clinicalenvironment. Infusion pumps are also advantageous in that they greatlyreduce the frequency of subcutaneous access events such as needle-basedshots. One example of a medicament that may be introduced by an infusionpump is a liquid formulation of insulin. Other exemplary medicamentsthat may be introduced by an infusion pump include, but are not limitedto, drugs that treat cancers and drugs that suppress the perception ofpain.

Many conventional infusion pumps have improved patient health andquality of life. Nevertheless, the present inventors have determinedthat conventional infusion pumps are susceptible to a wide range ofimprovements. By way of example, but not limitation, the presentinventors have determined that it would be desirable to provide aninfusion pump that is smaller, simpler, and less costly thanconventional infusion pumps, while also being more accurate thanconventional infusion pumps.

SUMMARY

An apparatus in accordance with at least one of the present inventionsincludes a medicament reservoir, a reservoir outlet in fluidcommunication with the medicament reservoir, and a trocar seal assembly,associated with the reservoir outlet and including a trocar with a rodand a sharp end that is movable relative to the reservoir outlet,configured to prevent medicament from flowing through the reservoiroutlet when the trocar is in a first position and to permit medicamentflow through the reservoir outlet in response to the trocar being movedfrom the first position. The present inventions also include infusionpumps with such apparatus.

An apparatus in accordance with at least one of the present inventionsincludes a medicament reservoir, a reservoir outlet in fluidcommunication with the medicament reservoir, a fill port in fluidcommunication with the medicament reservoir, and a fill plug sealassembly, associated with the fill port and the reservoir outlet andincluding a core pin, configured to prevent medicament from flowingthrough the reservoir outlet when the core pin is in a first positionand to permit medicament flow through the reservoir outlet in responseto the core pin being moved from the first position. The presentinventions also include infusion pumps with such apparatus.

The features and attendant advantages of the present inventions willbecome apparent as the inventions become better understood by referenceto the following detailed description when considered in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed description of exemplary embodiments will be made withreference to the accompanying drawings.

FIG. 1A is a perspective view of an exemplary infusion pump system in anassembled state.

FIG. 1B is an exploded perspective view of the infusion pump systemillustrated in FIG. 1A, including a durable assembly and a disposableassembly.

FIG. 2 is a top view of certain components of the infusion pump systemillustrated in FIGS. 1A and 1B.

FIG. 2A is a schematic view showing a use of the infusion pump systemillustrated in FIGS. 1A and 1B.

FIG. 2B is a schematic view showing another use of the infusion pumpsystem illustrated in FIGS. 1A and 1B.

FIG. 3A is a perspective view of an exemplary durable assembly.

FIG. 3B is a perspective view of certain components of the durableassembly illustrated in FIG. 3A.

FIG. 4A is a perspective view of an exemplary disposable assembly.

FIG. 4B is a perspective view of certain components of the disposableassembly illustrated in FIG. 4A.

FIG. 5A is a perspective view of certain components of a durableassembly and a disposable assembly of an exemplary infusion pump system.

FIG. 5B is a perspective view of the components of the exemplary durableassembly illustrated in FIG. 5A.

FIG. 5C is a perspective view of the components of the exemplarydisposable assembly illustrated in FIG. 5A.

FIG. 6 is a perspective section view of components of the exemplaryinfusion pump system of FIG. 5A, revealing a gap between certaincomponents of the durable and disposable assemblies.

FIG. 7 is a front view showing a patient's skin being cleaned.

FIG. 8 is a flow chart illustrating an exemplary disposable assemblyremoval and replacement method.

FIG. 9A is a perspective view of another exemplary infusion pump systemin an assembled state.

FIG. 9B is a perspective view of an exemplary durable assembly of theinfusion pump system of FIG. 9A.

FIG. 9C is a perspective view of certain components of the durableassembly illustrated in FIG. 9B.

FIG. 9D is a perspective view of an exemplary disposable assembly of theinfusion pump system of FIG. 9A.

FIG. 9E is a perspective view of certain components of the disposableassembly illustrated in FIG. 9D.

FIG. 10A is a perspective view of certain exemplary components of adisposable assembly.

FIG. 10B is an exploded perspective view of certain componentsillustrated in FIG. 10A.

FIG. 11A is an exploded section view of certain exemplary components ofa disposable assembly.

FIG. 11B is a section view of the components of FIG. 11A, shown in theirassembled positions.

FIGS. 11C-11F are section views showing additional exemplary componentsfor use with the components of FIG. 11A, shown in their assembledpositions.

FIG. 12 is a section view showing certain alternative components of adisposable assembly.

FIG. 13A is a side view showing additional alternative components of adisposable assembly.

FIG. 13B is a section view of certain exemplary components of theassembly of FIG. 13A.

FIG. 13C is a ninety degree section view of the components of FIG. 13B.

FIG. 13D is a side view of certain exemplary components of the assemblyof FIG. 13A, shown in a pre-dispensing or a storage position.

FIG. 13E is a ninety degree section view of the components of FIG. 13D,shown after the button of FIG. 13D has been pressed.

FIG. 13F is a side view of certain components of the assembly of FIG.13D.

FIG. 13G is a section view of the components of FIG. 13F.

FIG. 13H is a section view of certain exemplary components of theassembly of FIG. 13A, shown in a pre-dispensing or a storage position.

FIG. 13J is a section view of the components of FIG. 13H, shown afterthe button of FIG. 13H has been pressed.

FIG. 13K is a section view of certain exemplary components of theassembly of FIG. 13A.

FIG. 13M is a close-up section view of a portion of FIG. 13K.

FIG. 13N is a section view taken along line 13N-13N in FIG. 13M.

FIG. 13P is a side view of certain exemplary components of the assemblyof FIG. 13A, shown in a pre-dispensing or a storage position.

FIG. 13Q is a perspective view of certain components of the assembly ofFIG. 13P.

FIG. 14A is a perspective view showing alternative components of adisposable assembly.

FIG. 14B is a partially exploded section view of certain exemplarycomponents of the assembly of FIG. 14A.

FIG. 14C is a perspective view of certain components of the assembly ofFIG. 14A.

FIG. 14D is a perspective view showing additional components of theassembly of FIG. 14A.

FIGS. 15A and 15B are side views showing alternative components of adisposable assembly.

FIGS. 16A-16C are perspective section views showing additionalalternative components of a disposable assembly, shown in apre-dispensing or a storage position.

FIG. 16D is a perspective section view of the components of FIGS.16A-16C, shown after the button of FIG. 16C has been pressed.

FIGS. 17A-17C are perspective section views showing further alternativecomponents of a disposable assembly, shown in a pre-dispensing or astorage position.

FIG. 17D is a perspective section view of the components of FIGS.17A-17C, shown after the button of FIG. 17C has been pressed.

FIG. 17E is another section view of the components of FIGS. 17A-17C,shown after the button of FIG. 17C has been pressed.

FIG. 18A is a side view of certain exemplary components that may be usedwith a disposable assembly, shown in a pre-dispensing or a storageposition.

FIG. 18B is a side view of the components of FIG. 18A, shown with anadditional exemplary component and in a pre-dispending or a storageposition.

FIG. 18C is a perspective view of the components of FIG. 18B, shown in apre-dispensing or a storage position.

DETAILED DESCRIPTION

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

It should also be noted here that the specification describes structuresand methods that are especially well-suited for the subcutaneousdelivery of high concentration insulin (i.e., U-200 insulin and above)such as U-500 insulin as well as lower concentration insulin such asU-100 insulin. Nevertheless, it should be appreciated that the presentinventions are applicable to a wide variety of infusion pumps andmedicaments. By way of example, but not limitation, the inventions mayemploy, for fluid displacement, a reservoir with a plunger, a fluiddisplacement device in the form of a plunger pusher, and a drivemechanism that includes a motor, or other fluid displacement devices,regardless of the type of reservoir employed, piston pumps (e.g.,electromagnet pumps), MEMS pumps, peristaltic pumps and any othersuitable pumps as well as corresponding drive mechanisms. Exemplaryinfusion pumps that include a reservoir with a plunger, a fluiddisplacement device in the form of a plunger pusher, and a drivemechanism are described in U.S. patent application Ser. No. 12/890,207,filed Sep. 24, 2010, and corresponding U.S. patent publication number2012/0078170, both of which are incorporated by reference in theirentireties, and in U.S. provisional patent application Ser. No.62/057,273, filed Sep. 30, 2014, corresponding U.S. patent applicationSer. No. 14/869,906, filed Sep. 29, 2015, and corresponding U.S. patentpublication number 2016/0089491, each of which are incorporated byreference in their entireties, and in U.S. provisional patentapplication Ser. No. 62/117,565, filed Feb. 18, 2015, corresponding U.S.patent application Ser. No. 15/042,093, filed Feb. 11, 2016, andcorresponding U.S. patent publication number 2016/0235913, each of whichare also incorporated by reference in their entireties. The presentinventions are also applicable to medicaments such as, for example,drugs to mask pain, chemotherapy and other cancer related drugs,antibiotics, hormones, GLP-1, Glucagon, various other drugs that includelarge molecules and proteins that may require a high level of deliveryaccuracy, as well as to relatively high concentration insulin (i.e.,U-200 insulin and above) such as U-500 insulin, as well as lowerconcentration insulin, such as U-100 insulin. Aforementioned U.S. patentpublication number 2012/0078170, U.S. provisional patent applicationSer. No. 62/057,273, U.S. patent application Ser. No. 14/869,906, andcorresponding U.S. patent publication number 2016/0089491 each alsodescribe patient interaction with and use of infusion pumps such as theexemplary infusion pumps described herein.

As noted above, some ambulatory infusion pumps are intended to be wornon a belt, carried in a pocket, or otherwise supported within a holderof some kind (referred to collectively as “pocket pumps”). Such infusionpumps transfer fluid from a reservoir to an infusion set by way of anelongate tube. Subcutaneous access may be obtained by way of a cannulain the infusion set. Other ambulatory infusion pumps are intended to beadhered to the skin above the delivery site (sometimes referred to as“patch pumps”). Here, the cannula or other subcutaneous access devicemay extend directly from the infusion device. Given these modes of use,patients typically prefer the device to be as small as possible so it ismore comfortable, less obtrusive, and less visible. In addition,patients want a device that is easy and convenient to use.

An exemplary ambulatory infusion system, which is generally representedby reference numeral 100 in FIGS. 1A, 1B, and 2, includes a durableassembly 200 and a disposable assembly 300. Exemplary durable assembly200 includes a housing 202, one or more batteries or other energy supply221, one or more capacitors or other energy storage 222, amicroprocessor 223, a coil assembly 224 (which functions as a motorstator), and one or more Hall effect sensors 225. Exemplary disposableassembly 300 includes a baseplate 350 supporting components such as amagnetic motor rotor 331, a gear train 332 including lead screw drivegear 333 in a reservoir support block 337, and a lead screw 334 attachedto plunger 335, which is positioned in a medicament reservoir 336 thatis mounted to the reservoir support block 337. The exemplary plunger 335includes a core and a plurality of seals on the core. A cover 302, underwhich some or all of the magnetic motor rotor 331, gear train 332 (withdrive gear 333), lead screw 334, plunger 335, and medicament reservoir336 are located in various embodiments, may be mounted to the baseplate350.

The lead screw drive gear 333, lead screw 334, plunger 335, medicamentreservoir 336 and reservoir support block 337 may also be referred tocollectively as a “reservoir assembly.” Other exemplary reservoirassemblies, durable assemblies, and seal assemblies that may be employedin, for example, infusion system 100 are described below with referenceto FIGS. 9D-18C.

The exemplary disposable assembly 300 may be secured to the exemplarydurable assembly 200, as shown in FIGS. 1A and 2. To that end, theexemplary housing 202 includes a top wall 204, bottom walls 206 a and206 b and a side wall 208 that together define a relatively thin housingportion 210 and a relatively thick housing portion 212. An indentation214 is formed in the relatively thick portion 212. The exemplary cover302 includes top walls 304 a and 304 b and a side wall 306 that togetherdefine a relatively thin cover portion 308 and a relatively thick coverportion 310. A portion of the baseplate 350 is not covered by the cover302, thereby defining a recess 312 that is bordered by a wall 314 thatextends around the baseplate (see also FIG. 4B). When the durable anddisposable assemblies 200 and 300 are secured to one another in themanner illustrated in FIG. 1A, the relatively thick portion 212 of thehousing 202 will reside in the recess 312 of the disposable assembly 300(with the wall 314 in the indentation 214). The relatively thin portion210 of the housing 202 will reside on the top wall 304 b of the cover302. The cover 302 also includes a projection 316 that mates with arecess 216 on the housing 202. Additionally, as is discussed in greaterdetail below, the disposable assembly 300 may be configured fordifferent medicaments, such as different medicament concentrations,different medicament amounts, or different modes of system operation.

In other implementations, the cover 302 may be configured to cover fewerthan all of the components on the baseplate 350. For example, a covermay be configured such that the magnetic motor rotor 331 and a portionof the gear train 332 are not under the cover, while the remainingcomponents are under the cover. In still other implementations, thecover 302 may be omitted and the durable assembly 200 may be configuredto cover all of the components on the baseplate 350. In yet otherimplementations, what is referred to in the present application as the“durable” assembly, may be disposable, resulting in a fully disposablesystem.

As discussed in U.S. patent publication number 2012/0078170 describedabove, and in U.S. application Ser. No. 13/300,574, filed Nov. 19, 2011,and corresponding U.S. patent publication number 2012/0184907, and inU.S. application Ser. No. 13/475,843, filed May 18, 2012, andcorresponding U.S. patent publication number 2013/0138078, each of whichare incorporated by reference in their entireties, ambulatory infusionsystems that employ a reservoir on a baseplate may be configured fordifferent types of use. For example, disposable assembly 300 may beadhered to the patient's skin and may be used in conjunction with acannula (not shown) that is operatively connected to the reservoir 336so that the system 100 may be deployed as a “patch-pump,” as shown inFIG. 2A. Alternatively, as shown in FIG. 2B, the baseplate 350 ofdisposable assembly 300 may be configured to operably connect thereservoir 336 to an infusion set 382 (e.g., by way of the illustratedinfusion set tube and a connector 380 shown in FIGS. 1B and 2) so thatthe system 100 may be deployed as a “pocket pump,” a “belt-worn pump” orsome other wearable pump. In other words, using the same durableassembly 200, the user may configure the system for use as “pocket pump”or a “patch pump” by simply selecting the appropriate disposableassembly and attaching the disposable assembly to the durable assembly.The user may also switch from one configuration to another, by simplyremoving one disposable assembly and replacing it with anotherdisposable assembly. The connector 380 may also be used as a fill port,as discussed below.

It should therefore be noted that the present inventions include kitsthat contain various combinations of disposable assemblies, where atleast two of the disposable assemblies may be different. Additionally oralternatively, kits or other packages may include various disposableassembly components, such as an infusion set and/or cannula inserter.Kits may also include a durable assembly. The disposable assemblies insuch kits may also include the detection/identificationinstrumentalities discussed below. The components of the present kits(e.g., combination of various disposable assemblies and/or components)may be stored in a common package, with individual packages for eachcomponent if necessary, and provided to the user in the common package.Other components that may be provided in such kits include, but are notlimited to, inserters that are preloaded with a cannula, and cleaningswabs. A recharger may also be provided in a kit that includes a durableassembly.

In addition to disposable assembly packaging and labeling, the differentdisposable assemblies may include visual cues to differentiate thevarious disposable assemblies. For instance, disposable assemblies withdifferent concentrations of medicament or different medicament fillvolumes may use different colors for the reservoir and/or baseplate ofthe disposable assembly, or mechanical features that ensure disposablesare only able to attach to correctly programmed durables.

It should also be noted here that, but for the issue of priming, thedispensing procedures associated with an infusion system “patch pump”configuration, which may include a durable assembly 200 and a disposableassembly 300, are substantially the same as the dispensing proceduresassociated with a “pocket pump” configuration, which may also include aninfusion set 382 (see FIG. 2B). With a “patch pump” configuration,priming is not necessary because the volume of the associated cannulawill be very small and there is a direct connection between the cannulaand the medicament reservoir. Priming is, however, required to fill theinfusion set tube (FIG. 2B) in a “pocket pump” configuration prior tothe onset of medicament delivery. For instance, 20-30 μl may be requiredto fill the entire infusion set tube and, accordingly, the primingprocedure may involve the rapid delivery of 10-15 IUs of U-500 insulinto the tube. The present inventors have determined that it would beadvantageous to prevent users from initiating a priming procedure whenthe system is in the “patch pump” configuration, with a cannulapositioned to deliver medicament essentially directly from themedicament reservoir to the patient, because rapidly delivering 10-15IUs of insulin to the patient could adversely affect patient health.

To prevent such undesirable outcomes, and for user convenience in othersituations involving the choice between a variety of disposableassemblies (such as disposable assemblies with reservoirs containingdifferent medicaments, different concentrations of a medicament, and/orvarying amounts of medicaments), at least some of the present disposableassemblies may be provided with a baseplate identification device and atleast some of the present disposable assemblies may be provided withstructure that cooperate with a baseplate identification device in sucha manner that the durable assembly microprocessor/controller can make a“baseplate type” determination. Exemplary baseplate identificationinstrumentalities and methodologies may be as described inaforementioned U.S. patent publication numbers 2012/0078170,2012/0184907, and 2013/0138078. In addition, baseplate identificationmay be performed mechanically. For instance, a pin or rib may preventattachment of certain disposable assemblies with certain durableassemblies. Additionally or alternative, certain durable assemblies willsimply not function with certain disposable assemblies.

Alternatively, the patient or a clinician may program the system, suchas via a remote control, to indicate the type of disposable assemblyattached. In a manner such as this, a patient can access a variety ofmedicaments for use with a single durable assembly.

Once the “baseplate type” determination is made (e.g., “patch pump”disposable assembly 300 versus a “pocket pump” with infusion set 382attached), the durable assembly will proceed in a manner, or mode ofoperation, that is appropriate for the attached disposable assembly. Forexample, if “patch pump” disposable assembly 300 is detected, thedurable assembly controller will not include priming as part of thedelivery process and, in some implementations, will prevent the userfrom manually implementing a priming procedure. If, on the other hand, a“pocket pump” disposable assembly is detected, then the delivery processmay include appropriate priming of the infusion set tube.

Whether configured as a “pocket pump” or a “patch pump,” the system maybe configured to provide basal delivery of medicament in accordance witha delivery profile provided by a physician by way of a clinician'sprogramming unit. For example, the system may include a program thatstores a number of delivery profiles (e.g., delivery profiles associatedwith a 24-hour delivery cycle, delivery profiles for particularsituations such as sleep or illness, and the like). Each deliveryprofile specifies multiple doses (or pump “operations”) over time, e.g.,a particular number of doses at particular times or a particular numberof doses per unit time. In some implementations, a dose may be thevolume associated with the minimum controllable displacement of theplunger 335. The system may also be configured to provide bolus deliveryin response to an instruction from a patient remote control 1000 (FIG.2A). A bolus instruction may come in response to a high glucose levelmeasurement in the case of a diabetic patient, an increase in pain levelin the case of a pain management patient, or some other symptom. Thesystem may also be configured to perform other functions, such as endingmedicament delivery in response to instructions from patient remotecontrol 1000.

The present infusion pumps may be used in conjunction with a widevariety of remote controls. Such remote controls may be used to, forexample, allow the user to transmit instructions to the durable assembly200 or facilitate communication between durable assembly 200 and theuser (e.g., an alarm condition message or other message concerning theconditions of system 100). An exemplary remote control 1000 (FIG. 2A)may be configured to facilitate one, some, or all of the followingoperations: (1) turning the remote control 1000 on or off, (2)associating (or “assigning”) the remote control 1000 to the durableassembly 20, (3) obtaining status information such as medicament level,battery charge level, and/or alarm conditions, (4) silencing the durableassembly alarm, (5) selecting options that may be associated with thedurable assembly alarm such as type of alarm (audible, palpable, and/orvisible) and strength/volume of alarm, (6) connecting remote control1000 to a computer to, for example, update remote control or durableassembly firmware, load and delete delivery profiles stored in thedurable assembly or remote control, and otherwise reprogram the durableassembly or remote control, (7) selecting medicament options such asmedicament concentrations, (8) selecting and initiating a storedmedicament delivery profile, (9) increasing and decreasing medicamentdose rate, and/or (10) pausing a dispensing operation. A user may pausedelivery in order to remove or replace a patient applied structure(e.g., a disposable assembly), adjust for a current or anticipatedchanged body condition (e.g., low glucose, vigorous exercise), follow aphysician's suggestion, or disconnect the durable assembly from the bodyfor any other reason.

The exemplary remote control 1000 (FIG. 2A) may be configured togenerate an indicator, based on information from a microprocessor 223for durable assembly 200, that is indicative of, for instance, theamount of time remaining in the current dispensing program, the amountof time until the next disposable assembly replacement, etc. Theindicator may be audible, visible, palpable, or combinations thereof. Atime remaining indicator may be useful for a variety of reasons. Forexample, knowledge of the time remaining prior to next disposableassembly replacement allows the patient to determine, based at least inpart on the current time of day and upcoming events (e.g., travel orsleep), whether or not it would be more convenient to replace thedisposable assembly at a time prior to the end of the dispensingprogram.

As described above, parts of the present systems may be considered thereusable parts, while other parts may be considered the disposableparts. In the illustrated embodiments, the durable assembly 200, whichmay include structures such as microprocessor 223 and coil assembly 224,is reusable, while exemplary disposable assemblies 300, which mayinclude structures such as a motor rotor 331 and reservoir 336 on abaseplate 350, are disposable. In other embodiments, the present systemsmay be fully disposable.

With respect to dimensions, some embodiments of the exemplary infusionpump system 100 may have the following dimensions: length dimensions of35 mm+/−1.0 mm, 35 mm+/−0.10 mm, or 35 mm+/−5.0 mm; width dimensions of30 mm+/−1.0 mm, 30 mm+/−0.10 mm, or 30 mm+/−5 mm; and overall thicknessor height dimensions of 8.5 mm+/−1.0 mm, 8.5 mm+/−2 mm, or 8.5 mm+/−0.10mm. Suitable housing materials include, but are not limited to, plasticor other materials having a modulus of elasticity of 0.2-1.0 millionpsi.

Exemplary durable assembly microprocessors and associated circuitry;rechargeable batteries and associated battery rechargers and rechargingmethods; battery and recharging management; temperature sensors; andexemplary alarms and alarm conditions are described in more detail inaforementioned U.S. patent publication numbers 2012/0078170,2012/0184907, and 2013/0138078.

Turning now to FIGS. 3A and 3B, an exemplary durable assembly 200 mayinclude a power source such as one or more batteries 221, temporarypower storage such as one or more capacitors 222 (see FIGS. 2 and 5B), acontroller such as microprocessor 223, a coil assembly 224, and a halleffect sensor 225. Those of skill in the art will appreciate thatincluding the motor's coil assembly 224 and all other electronics withinthe durable assembly 200 reduces the cost and complexity of disposableassembly 300. In addition, the microprocessor 223 provides flexibilityto include features such as user data storage, programs,programmability, adjustability, a display, buttons, wirelesscommunication protocols, or the like to the pump 100. Durable assembly200 may also be molded with locking features that snap onto thedisposable assembly 300, but that also allow removal of the durableassembly 200 from the disposable assembly 300 either while thedisposable assembly remains in place on the patient (after medicamentdelivery has been paused), or after the entire system has been removedfrom the patient.

The power source may be one or more commercially available batteries,such as a commercially available zinc-air battery or lithium polymerbattery. The batteries may be selected to have sufficient capacity tooperate the system for certain delivery amounts or delivery times, suchas for over 400 units of delivered insulin. The optional power storagemay be one or more commercially available capacitors or super-capacitorsor other temporary storage device(s).

Turning now to FIGS. 4A and 4B, an exemplary disposable assembly 300 mayinclude baseplate 350 and components such as a reservoir 336, a plunger335 within the reservoir and connected to lead screw 334, and a magneticmotor rotor 331 mechanically attached through gear train 332 to affectrotation of the lead screw drive gear 333, which causes translation ofthe lead screw 334 and plunger 335 within reservoir 336. The cover 302is positioned over these components in the illustrated embodiment. Theexemplary baseplate 350 includes an adhesive backing for attachment tothe patient with a removable adhesive cover. The baseplate 350 may alsobe molded with baseplate locking features that snap onto the durableassembly 200 (such as magnets molded into the housings of eachassembly), and that also allows removal of the durable assembly 200 fromthe disposable assembly 300.

Referring to FIGS. 2 and 4B, the exemplary reservoir 336 includes abarrel 338 with an inner surface 340 defining a fluid storage volume 342and an oval cross-section, but other shapes (such as circular) arepossible as is discussed below with reference to FIGS. 10A-18C. Aplunger 335 with a matching cross-sectional shape fits within the barreland carries a fluid seal such as, but not limited to, o-rings, to sealthe medicament within the storage volume 342. The exemplary plunger 335is formed from rubber and includes three o-ring seals. The reservoir 336includes the aforementioned connector 380 that may be used for fillingreservoir 336, or for attaching a cannula for “patch-pump” typeconfigurations, or for connecting (potentially via an appropriateadapter(s)) an infusion set for “pocket-pump” type configurations. Theplunger 335 moves within the barrel 338 to vary the volume of medicamentwithin the storage volume 342. Reservoir 336 may be, for instance,prefilled (or user-filled) with U-500 insulin in various volumes to suitthe patient use profile. In other instances, lower concentrations ofinsulin, such as U-100 insulin and U-200 insulin, may be employed. Aplug may be inserted in the connector 380 to maintain a sterileenvironment until use. The patient would remove the plug prior to use,in those instances.

Additional exemplary baseplates for use with the disposable assembliesof the present inventions, as well as exemplary cannula designs, fluidicconnection between a medicament reservoir and the cannula, cooperationbetween the cannula and disposable assemblies (for instance, to preventaxial movement of the cannula relative to the baseplate and patient),attachment of an infusion set to the reservoir of the disposableassembly, configurations and uses of a non-delivery baseplate,arrangements and structures for attaching disposable and durableassemblies, skin adhesive designs, and various occlusion sensors, may beas described in U.S. patent application Ser. No. 12/890,207, filed Sep.24, 2010 and corresponding U.S. patent publication number 2012/0078170,as well as aforementioned U.S. patent publication numbers 2012/0184907and 2013/0138078.

Turning now to FIGS. 5A-5C and the illustrated two-piece motor, themotor's coil assembly 224 (and a Hall effect sensor 225) of the durableassembly 200 are positioned above the magnetic motor rotor 331 that ispart of the disposable assembly 300. An exemplary multi-pole motor rotor331 may be disc-shaped and have a 9.8 mm outer diameter, 5.2 mm innerdiameter, and 0.8 mm thickness. Another example motor rotor may have an11 mm outer diameter, 5 mm inner diameter, and 1.2 mm thickness.Multi-pole motor rotors of this type typically cost less than 5 centsper piece, helping control the total cost of disposable assembly 200.The motor rotor 331 is also parallel to the baseplate 350, i.e., themotor rotor axis of rotation is perpendicular to the baseplate, in theillustrated embodiment. The microprocessor 223 directs rotation of motorrotor 331 by sequentially energizing the coils of motor coil assembly224 to create an electromagnetic torque coupling between the motor coilassembly 224 and the motor rotor 331. The position/orientation of therotor's poles relative to the rotating magnetic field generator (coilassembly 224) is measured by back EMF, a rotary encoder, a hall effectsensor 225 (FIG. 5A), or the like. For instance, a Hall effect sensormounted on the coil windings may be used to supply the microprocessor acount, a tachometer signal, or rotor position, allowing low-costclosed-loop control of the rotor speed. Brushless motors of this typeare typically 85-90% or more efficient, and run very cool. While theremay be variations in construction, the face-to-face stator coils andflat rotor plate shown in FIGS. 5A-5C provide a compact design. Inaddition, more coils and/or Hall effect sensors may be used.

As can best be seen in FIG. 6, between the motor coil assembly 224 andmotor rotor 331 is a gap 240. Some or all of the gap 240 may be definedby (and occupied by) portions of the housing 202 and the cover 302,i.e., the housing bottom wall 206 a and the cover top wall 304 b in theillustrated implementation. In other implementations, the gap 240between the between the motor coil assembly 224 and motor rotor 331 maybe occupied by only a portion of the durable assembly housing, or only aportion of the disposably assembly cover, or no structure at all and maysimply be an air gap. The size of the gap, which is defined by thedistance between the motor coil assembly 224 and the motor rotor 331, istypically about 0.5 mm to 2.0 mm. As such, there is no gear engagementor other mechanical connection between the durable assembly 200 anddisposable assembly 300. And as described earlier, all electronics maybe positioned within the durable assembly 200, with the energy needed bythe disposable assembly 300 transferred by electromagnetic torquecoupling, which is a coupling without direct mechanical coupling orelectrical contact from the durable assembly 200. This exemplary designaffords the additional advantage of being relatively simple to makewaterproof, or at least water resistant.

As described above, rotation of motor rotor 331 drives gear train 332,causing rotation of lead screw drive gear 333, which in turn affectstranslation of the lead screw 334 and plunger 335, which is attached tolead screw 334. In this manner, electromagnetically generated torque iscreated when electromagnetic energy supplied by durable assembly 200 istransformed into mechanical forces within the disposable assembly 300that advance plunger 335. A ratchet (not shown) or other similar devicemay be used to prevent back drive of gear train 332. As plunger 335 isdriven through reservoir 336, medicament is dispensed precisely,corresponding to the precision movements of the gears and motor rotor.With the entire gear train, lead screw drive gear, lead screw, andplunger all permanently contained in the disposable assembly 300, thereis no need to retract any plunger components into the durable assembly200 prior to separation from the disposable assembly 300. As a result, afurther advantage of this exemplary design is greatly reduced energyconsumption, which allows use of, for instance, a primary battery(ies)as a power source.

Use of an exemplary system 100 will now be described. At the most basiclevel, a patient's use of the exemplary infusion pump systems (e.g.,system 100 in FIGS. 1A-2B) involves obtaining a new disposable assembly300, connecting the disposable assembly to the durable assembly 200,peeling the liner from the baseplate adhesive layer, gainingsubcutaneous access, and initiating a medicament delivery operation. Insome instances, use may involve additional steps such as attaching acannula to connector 380 of the disposable assembly and removing acannula cap, if necessary. Various aspects of the basic operation of thepresent systems are described below. Operation of a system does notnecessarily require all of the steps each time the system is deployed,and the order of some of the steps may be changed. Operation is alsodiscussed below, in the exemplary context of the above-described durableassembly 200 and disposable assembly 300 used as a patch pump, throughthe use of a flow chart (FIG. 8). The discussion is, however, equallyapplicable to other patch pump implementations, as well as to pocketpump implementations with minor variations. Also, unless otherwiseindicated, the actions and determinations performed by the durableassembly 200 are controlled by the durable assembly microprocessor andfurther references to the controller are limited in the interest ofbrevity.

Referring to FIG. 8, use of the present systems may involve removal of adisposable assembly from a durable assembly and the replacement of thedisposable assembly. This may occur when the medicament reservoir isempty (as described in more detail in U.S. patent application Ser. No.12/890,207 and corresponding U.S. patent publication number2012/0078170) (Step S101) and a “replace disposable assembly” message oralert is presented (Step S102), or when the durable assembly controllerreceives a user-initiated “replace disposable assembly” signal from aremote control 1000 (Step S103). The user may desire to replace adisposable assembly before the medicament reservoir is empty for avariety of reasons such as, for example, to accommodate the user's sleepor travel schedule, when the medicament exhibits a loss ofeffectiveness, when a dispensing problem arises, or due to a prescribedchange in medicament.

The user may then obtain, possibly from storage in a refrigeratordepending on medicament requirements, a new pre-filled disposableassembly 300 or may then obtain a new disposable assembly and fill thedisposable assembly with medicament (Step S104). The durable assembly200 and disposable assembly 300 may then be removed from the skin,separated, and the disposable assembly 300 discarded (Steps S106 andS107).

Next, the new disposable assembly 300 may be attached to the durableassembly 200 (Step S109). The user should clean the skin surface S ontowhich the baseplate 350 of disposable assembly 300 will be adhered (FIG.7, and Step S116 of FIG. 8). Then the user peels off the baseplateadhesive liner to expose the baseplate adhesive layer (Step S117) andremoves cannula cap (when present) (Step S118). In the exemplary use ofFIG. 8, the disposable assembly 30 is supplied with a cannula in fluidcommunication with the reservoir storage volume. In other embodiments, acannula inserter may be attached to the system, which may be triggeredto insert the cannula after the system is placed against the skin.Exemplary inserters are described in U.S. patent publication number2013/0138078.

Returning to the steps in FIG. 8, the system 100 including durableassembly 200 and disposable assembly 300 may be positioned over asuitable body location and pressed gently to adhere the adhesive layerto the skin surface S and, once the system has been adhered (Step S119),the inserter may be actuated to position the end of a cannula below theskin. It should be noted that in those implementations which do notinclude an inserter, and instead simply include a hollow needle (or acannula and removable trocar arrangement) that projects outwardly fromthe bottom surface of the system, the user need only adhere the adhesivelayer to position the needle or cannula below the skin. The trocar, ifemployed, may then be removed. Finally, if necessary, the remote control1000 may be used to initiate a particular medicament delivery operation(Step S120). The delivery operation may follow a predetermined deliveryprofile (e.g. a particular basal rate, a series of time-spaced bolusdeliveries, or some combination thereof) that is equated to motor rotorrotations, at particular rates and times, required to deliver medicamentin accordance with the profile. Alternatively, the profile may be inputby the user with the remote control 1000 and stored by the durableassembly microprocessor. For example, the remote control may store anumber of different delivery profiles and bolus deliveries from whichthe patient can choose. Such profiles may correspond to, for example anddepending on the medicament, days where vigorous exercise is expected,days where it is not, incidences of increased pain, etc. Alternatively,or in addition, the profile stored in the durable assemblymicroprocessor may be set by a clinician's programming unit. In such acase, as in the case of different disposable assemblies 300 providedwith different specified delivery rates, a remote control may not beneeded to initiate, e.g., basal delivery.

The discussion above is also applicable to use of the “pocket pump”system as shown in FIG. 2B. Minor variations in the above-describedprocedure include, for example, use of an infusion set 382 instead of acannula, attaching the infusion set to connector 380, potentially via anadapter (which may vary with the type of infusion set 382), and primingof the infusion set tube.

Another exemplary ambulatory infusion system, which is generallyrepresented by reference numeral 100 a in FIG. 9A, includes a durableassembly 200 a and a disposable assembly 400. System 100 a issubstantially similar to system 100. Here, however, the intersection ofthe top walls is primarily linear. Additionally, the disposable assembly400 has a recess 316 a which mates with a corresponding projection 216 aon the durable assembly 200 a. The projection 216 a and recess 316 a arelocated at the outer perimeter of the assembled system 100 a.

Exemplary durable assembly 200 a, shown in more detail in FIGS. 9B and9C, may include a housing 202 a, one or more batteries or other energysupply 221 a, one or more capacitors or other energy storage (notshown), a microprocessor (not shown), and a coil assembly 224 aincluding one or more Hall effect sensors (not shown). Exemplarydisposable assembly 400, shown in more detail in FIGS. 9D and 9E, mayinclude a baseplate 450 supporting components such as a magnetic motorrotor 431, a gear train 432 including lead screw drive gear 433, and alead screw 434 attached to plunger assembly 435 which is positioned in amedicament reservoir 436. The magnetic motor rotor 431 may bemechanically attached through gear train 432 to affect rotation of thelead screw drive gear 433, which causes translation of the lead screw434 and the plunger 435 within reservoir 436. Reservoir 436 may be, forinstance, prefilled with U-500 insulin or U-100 insulin or otherconcentrations of insulin to suit different patient use profiles, or maybe user-fillable by way of a fill port 415. A reservoir outlet 438 is influid communication with reservoir 436. A septum 446, which may formpart of a trocar seal assembly (such as those described below), ispositioned within the reservoir outlet. Disposable assembly 400 may besecured to durable assembly 200 a, as shown in FIG. 9A and as furtherdescribed in U.S. provisional patent application Ser. No. 62/057,273,corresponding U.S. patent application Ser. No. 14/869,906, andcorresponding U.S. patent publication number 2016/0089491.

The reservoirs may be, but are not required to be, prefilled. Prefilledreservoirs are advantageous for a variety of reasons. By way of example,but not limitation, some users prefer to avoid reservoir fillingprocedures because they are inconvenient and tend to involve needles.User-based refilling also increases the likelihood that air bubbles willbe introduced into the reservoir, while prefilling by the manufacturerof the reservoir and/or the medicament can be accomplished without anysubstantial introduction of air bubbles using, for example, a vacuumfilling procedure. Nevertheless, user-filled reservoirs may be employedin some instances. A variety of exemplary medicament reservoirs,including those that include pressure sensors (such as for sensingocclusion) and other sensors, are described in more detail inaforementioned U.S. patent publication numbers 2012/0078170,2012/0184907, and 2013/0138078.

While a prefilled reservoir would greatly improve the ease of use ofpatch and pocket pump technology, there are several challenges toproviding such prefilled reservoirs. By way of example but notlimitation, long-term storage of insulin has traditionally used glasscontainers with bromobutyl rubber stoppers, and this has been applied toprefilled insulin pens using glass syringe barrels with bromobutylplungers. The high coefficient of friction of bromobutyl on glassrequires a coating of silicone oil on the interior of the reservoir, sothe plunger may slide easily in the barrel during dispensing.Alternatively or additionally, as described in more detail in U.S.provisional patent application 62/117,565 filed Feb. 18, 2015,corresponding U.S. patent application Ser. No. 15/042,093, filed Feb.11, 2016, and corresponding U.S. patent publication number 2016/0235913,the reservoir assembly may utilize a dual seal system having a staticseal that minimizes water vapor loss during storage or pre-dispensing,and a dynamic seal that provides a low glide/break force when theplunger is moving during dispensing.

As another non-limiting example, any opening used to introducemedicament while filling the reservoir must then be properly sealed toprevent pre-dispensing fluid leakage and to limit water vapor lossduring any storage period. As yet another non-limiting example, thefilled reservoir also needs proper outlet seals along the dispensingpath, designed for medicament compatibility, and designed to limit vaporloss during any storage of a prefilled reservoir; and those seals need apassage, valve(s) or other means to ultimately allow medicamentdispensing. For instance, and as seen generally in FIGS. 10A and 10B, anexemplary trocar seal assembly 540 may be positioned in a reservoiroutlet 538 that is in fluid communication with reservoir 536. The trocarseal assembly 540 must prevent pre-dispensing fluid loss once thereservoir 536 is user-filled, or if pre-filled before being supplied tothe user, must prevent vapor loss during storage, but in both cases,allow dispensing of medicament from reservoir 536 though the reservoiroutlet 538 and trocar seal assembly 540 once properly activated by apatient. The exemplary trocar seal assembly 540 includes a cannula 541,a cannula insert 542, a combined drum/septum 543 a (with a drum 543 andintegral septum 546), and a trocar (not shown), and functions in themanner described below with reference to FIGS. 11A-11F. Trocar sealassembly 540 (and other trocar seal assemblies described below) may beincorporated into an infusion pump in, for example, the mannerillustrated in FIG. 9E.

A more specific exemplary embodiment is shown in FIGS. 11A-11F, wherereservoir outlet 638 with an inner surface 660 is in fluid communicationwith a fluid reservoir (such as, for example, the reservoir 536 in FIG.10A or the reservoir 636 in FIG. 12) via reservoir connection 639 (orsimilar, such as reservoir connection 839 best seen in FIGS. 14B and14C). A drum 643, made of rubber or similar conformable material, andwhich includes an outer surface 662, an inner surface that defines adrum outlet lumen (or “drum outlet”) 664, drum seals 644 on the outersurface, and trocar seals 645 on the inner surface, is positioned withinreservoir outlet 638. Drum 643 also includes a drum inlet lumen (or“drum inlet”) 649 in fluid communication with reservoir connection 639and drum outlet 664. The trocar seal assembly 640 (FIGS. 11E and 11F)comprises the drum 643, a septum 646 positioned above drum 643, acannula 641 and cannula insert 642, and a trocar 647 positioned throughseptum 646, drum 643, cannula insert 642, and cannula 641. Trocar 647includes an elongate rod, with an outer surface 666, and a sharp end668. As with drum 643, septum 646 may also be made of rubber, such assilicone rubber, or the like. Cannula 641 may be made ofpolytetrafluoroethylene (PTFE), such as TEFLON® PTFE, or otherbiocompatible polymeric material, and cannula insert 642 may be made ofmetal, such as stainless steel, or other relatively rigid biocompatiblematerial. Cannula insert 642 holds cannula 641 in place and sealscannula 641 against reservoir outlet 638. Additionally, cannula insert642 guides trocar 647 into place within cannula 641 during assembly andprevents the sharp end of the trocar from piercing the cannula. Thefluid reservoir may be made of cyclic olefin polymer (COP) or otherbiocompatible polymeric material and reservoir outlet 638 may be made ofcyclic olefin polymer (COP) or other biocompatible polymeric material.

In another exemplary embodiment, shown in FIG. 12, the drum and septumare integrated into a combined drum/septum 643 a with drum 643′ andintegral septum 646′. The entire body 643 a may be made of rubber orother conformable material, or a technique such as over-molding may beused to form body 643 a of multiple materials. The other componentsshown in FIG. 11A-11F may be used interchangeably with this exemplaryembodiment.

In the above exemplary embodiments, if the reservoir is filled withmedicament before delivery to a user (rather than user-filled asdescribed elsewhere in this application) trocar 647 is the primarypackaging seal for the medicament, so the medicament cannot travel fromthe fluid reservoir through the reservoir outlet 638 to cannula 641 byway of, in the illustrated example, reservoir connection 639, drum inlet649 and drum outlet 664. In the case of user-fill, the trocar 647 actsas a medicament seal and similarly prevents medicament leakage until theuser activates the pump. In either case, drum seals 644 engage outletinner surface 660 to seal the interface between the reservoir outlet 638and drum 643 or (combined drum/septum 643 a). While trocar 647 is inplace in a first (or “seal”) position (FIGS. 11E and 11F), trocar seals645 engage trocar outer surface 666 to seal the interface between trocar647 and drum 643 (or combined drum/septum 643 a), thereby preventingfluid flow through drum outlet 664 and to cannula 641. Trocar 647 may bemade of stainless steel, rigid plastic, ceramic, or similar rigidbiocompatible material, and is used to penetrate the skin and a shortdistance into the flesh, to make a channel for cannula 641. In at leastsome instances, the associated pump will be pressed against thepatient's skin, thereby driving cannula 641 and trocar 647 below theskin surface. Once cannula 641 is in place, trocar 647 may be moved to asecond (or “unseal”) position to permit fluid flow from reservoir outlet638 to cannula 641. For example, trocar 647 may be retracted into thepump 100/100 a, or removed from pump 100/100 a and the remainder of thetrocar seal assembly 640 (FIG. 11D) through septum 646 (or combineddrum/septum 643 a), thereby removing the trocar from drum outlet 664 topermit fluid flow. Septum 646 (or the septum portion of combineddrum/septum 643 a) will then seal end of drum outlet 664 opposite thecannula 641.

Another exemplary embodiment of a trocar being used as a medicament sealor a primary packaging seal is shown in FIGS. 13A-13Q. This exemplarytrocar seal assembly 740 includes a drum 743, a cannula 741, and atrocar 747. Drum 743 includes an outer surface 762, drum seals 744 onthe outer surface, an inner surface that defines a drum outlet lumen (or“drum outlet”) 764, and cannula seals 745 on the inner surface (FIGS.13B and 13C). Drum 743 is positioned within reservoir outlet 738, andfurther includes a drum inlet 749 in fluid communication with reservoirconnection 739 and drum outlet 764. Cannula 741 and trocar 747, when inthe pre-dispensing or storage position, are positioned within drum 743to seal the fluid path through drum 743 that is defined by drum outlet764, as described in more detail below.

Trocar 747 includes an elongate rod, with an outer surface 766, and asharp end 768, may be made of stainless steel, rigid plastic, ceramic,or similar rigid biocompatible material, and may be attached to button700, as is best seen in FIGS. 13F-13G. For instance, trocar 747, whichmay have an outer surface 766 with a diameter of about 0.20 mm (about0.008 inch), may be adhered to button 700, which may have an outerdiameter of about 10 mm (about 0.4 inch). As another example, trocar 747may be insertion molded into button 700, which may be made of COP,Delrin, polycarbonate, or other injection moldable polymeric material.As best seen in FIGS. 13D, 13E, 13K, 13M, and 13N, trocar 747 carriescannula 741, which may have an outer surface 770 that is in contact withthe cannula seals 745 and has a diameter of about 0.50 mm (0.020 inch).Cannula 741 may be made of peek, TEFLON® PTFE, or other polymericmaterial. Button 700 is attached to stem 702, which carries a stem hook704, such as a tab or rim. As may be best appreciated from the sectionviews of FIGS. 13G, 13H, and 13J, all these pieces may be, but are notnecessarily, made of the same material and may even be made as onepiece, such as by injection molding all at once. Stem 702 slides withintube 720 (FIGS. 13P-13Q), which may be made of the same or similarmaterials as button 700 and stem 702. Tube 720 has a stem catch 722 thatlatches with stem hook 704 to prevent stem 702 from disengaging fromtube 720. Similarly, tube 720 slides within cavity 755 of reservoiroutlet 738 (FIG. 13A), which has a tube catch 742 that latches with tubehook 724 to prevent tube 720 from disengaging from reservoir outlet 738.

When the associated disposable assembly is filled with medicament butthe pump is not yet dispensing, trocar seal assembly 740 acts as apre-dispensing seal or a primary packaging seal, with button 700 andtube 720 at their highest, fully extended positions, as depicted in FIG.13A. In this storage or pre-dispensing configuration, the end of cannula741 and tip of trocar 747 are positioned above the bottom of reservoiroutlet 738, as seen in FIG. 13A. For instance, the tip of trocar 747 andthe end of cannula 741 may be about 0.1 mm above the bottom of reservoiroutlet 738. In this storage or pre-dispensing configuration, wherecannula 741 and trocar 747 are in first (or “seal”) positions, cannulainlet 758 is not aligned with drum inlet 749, so medicament cannot flowthrough cannula inlet 758 and into cannula passage 759. In addition,cannula seals 745 engage cannula outer surface 770, thereby preventingflow out between the inner surface of drum 743 and the cannula outersurface. Cannula passage 759 (FIGS. 13M and 13N) is a channel along theinside of cannula 741 that allows passage of medicament down the lengthof cannula 741 and trocar 747, and out the distal end of cannula 741.

To initiate the flow of medicament through the pump, button 700 ispressed until stem 702 is entirely within tube 720, tube 720 is entirelywithin reservoir outlet 738, and button 700 is seated in the top, wideportion of cavity 755 within reservoir outlet 738. Pressing down button700 causes button spring 706 to compress about 0.9 mm (0.035 inch) (seeFIGS. 13D and 13E, and also 13H and 13J), which in turn causes thedistal tip of trocar 747 to extend about 0.9 mm (0.035 inch) past thedistal end of cannula 741 (see FIGS. 13D and 13E). When button 700 ispressed all the way down into the top, wide portion of cavity 755 todrive cannula 741 and trocar 747 to the second (or “unseal”) position,the distal end of trocar 747 penetrates the skin and extends about 6-8mm past the bottom of reservoir outlet 738, and into the patient'sflesh, carrying the distal end of cannula 741 with it. In this position,cannula inlet 758 is located between the cannula seals 745 above andbelow drum inlet 749 and is substantially aligned with drum inlet 749,which allows medicament to flow through reservoir connection 739,through drum inlet 749, through cannula inlet 758, into cannula passage759, and out cannula 741 (see FIGS. 13K, 13M, and 13N). Cannula passage759 may be a channel with a width W of about 0.15 mm (about 0.006 inch)and a depth D of about 0.05 mm (about 0.002 inch). Cannula passage 759is closed at the proximal end so medicament cannot flow up cannula 741into button 700 (see FIG. 13M). When button 700 is released by the user,button spring 706 will drive the button (and trocar 474) as shortdistance (e.g., 0.9 mm) away from outlet 738. The trocar 747 will movetowards, but not to, the first position, while the cannula 741 willremain in second position.

Another exemplary embodiment of a trocar being used as a medicament sealor a primary packaging seal is shown in FIGS. 14A-14D. This exemplarytrocar seal assembly 840 includes a drum 843, a cannula 841, cannulainsert 842, and a trocar 847. Drum 843 includes an inner surface thatdefines a drum outlet lumen (or “drum outlet”) 864. A septum 846 may bepositioned above drum 843, or the drum and septum may be integrated intoa combined drum/septum (not shown). The exemplary trocar 847 includes anelongate rod, with an outer surface 866, and a sharp end 668. In thisexemplary embodiment, reservoir outlet 838 is created as part of thebaseplate 850 of disposable assembly 800 (FIGS. 14A-14B), reservoirconnection 839 is a nipple protruding from and may be created as part ofthe reservoir 836 (FIGS. 14B-14C), and drum 843 includes a retainer 849a that holds drum 843 onto reservoir connection 839 and creates a sealedfluid connection between the nipple of reservoir connection 839 and thedrum inlet 849 (FIGS. 14B-14D). Drum 843 is positioned within reservoiroutlet 838 and includes trocar seals 845 (FIG. 14B) that engage theouter surface 866 of trocar 847 to form a seal around trocar 847 asdescribed in the embodiments above. Reservoir 836 and reservoirconnection 839 may be made of COP or other biocompatible polymericmaterial, drum 843 or the previously described optional combineddrum/septum may be made of bromobutyl rubber or similar elastomericmaterial, and septum 846 may be made of silicone rubber or otherresealable elastomeric material.

When disposable assembly 800 is filled with medicament but the pump isnot yet dispensing, trocar seal assembly 840 acts as a medicament sealor a primary packaging seal. While trocar 847 is in place within drum843 or the integrated drum-septum body in the first (or “seal”) positiondescribed above, trocar seals 845 engage trocar outer surface 866 toseal the interface between trocar 847 and drum 843 or integrated body toseal the fluid path through drum 843 (or combined drum/septum). As inearlier exemplary embodiments, trocar 847 may be made of stainlesssteel, or similar biocompatible material, and is used to penetrate theskin and a short distance into the flesh, to make a channel for cannula841, which may be made of TEFLON® PTFE or other biocompatible material.In at least some instances, the associated pump will be pressed againstthe patient's skin, thereby driving the cannula 841 and trocar 847 belowthe skin surface. Once cannula 841 is in place, the trocar may beretracted to a second (or “unseal”) position to permit fluid flow fromthe reservoir outlet to the cannula 841. For example, trocar 847 may beretracted into the pump 100/100 a, or removed from pump 100/100 a andthe remainder of the trocar seal assembly 840 through septum 846 or (acombined drum/septum), to permit fluid flow. Septum 846 (or the septumportion of a combined drum/septum) will then seal end of drum outlet 864opposite the cannula 841.

Another type of seal is a seal at a fill port where medicament isintroduced into the reservoir. In some cases, it may be desirable toprevent medicament from passing from a reservoir 636/836/936 through areservoir connection 639/739/839/939 until dispensing begins, and thismay be achieved with fill plug seal assembly 904/1004 in the fill port415/515/815/915. As can be seen in the exemplary embodiment of FIGS.15A-17E, a reservoir 936 may be filled with medicament through fill port915. To prevent medicament from traveling from reservoir 936 throughreservoir connection 939 to an attached reservoir outlet and cannula(not shown) before dispensing begins, a fill plug 910/1010 of fill plugseal assembly 904/1004 may be inserted into fill port 915 to blockpassage of medicament from reservoir 936 to reservoir connection 939.For instance, if it is preferable, during storage and/or beforedispensing, to prevent medicament from being positioned in reservoirconnection 639/739/839/939 and drum inlet 649/749/849, as may be thecase in the embodiments above, and instead to maintain all medicamentwithin reservoir 636/736/836/936 during storage and/or beforedispensing, the following embodiments, or their equivalent, may beemployed instead or in addition to the embodiments above.

In one exemplary embodiment of a seal at the fill plug, a fill plug sealassembly 904 includes a thin seal 980, such as a thin foil or othermaterial that is impermeable and compatible with the medicamentcontained in the reservoir when in an intact state, is used to sealreservoir 936, as shown in FIGS. 16A-16D. A fill plug 910, made ofrubber or other relatively conformable sealing material, is positionedin fill port 915. Fill plug 910 includes an inner surface that definesan inlet lumen 949. A core pin 940 may be positioned through the inletlumen 949 of fill plug 910, as shown in FIGS. 16B-16D. Core pin 940 mayhave a sharp tip 944 and may be attached to a push button 950 (FIGS. 16Cand 16D), which may or may not be removable from core pin 940. A fillplug outlet lumen 964 connects the inlet lumen 949 to the reservoirconnection 939.

When device 100/100 a is ready for use, and the patient wants medicamentto be dispensed from reservoir 936, push button 950 should be presseddown until it is fully seated in fill plug 910. As button 950 ispressed, core pin 940 advances from a first (or “seal”) position towardsreservoir 936, and sharp tip 944 penetrates seal 980 at a second (or“unseal”) position, allowing medicament to flow from reservoir 936,through fill plug 910 of fill plug seal assembly 904 (by way of lumens949 and 964), and through reservoir connection 939. Fill plug 910includes an outer surface 962 with seals 912 that engage the innersurface 960 of fill port 915 to prevent medicament from leaking outaround the outside of fill plug 910. Core pin seals 942 preventmedicament from leaking through the fill plug and around the outside ofcore pin 940 after sharp tip 944 has penetrated seal 980. Plug seals 912and core pin seals 942 may be made of rubber or other relativelyconformable sealing material, such as by injection molding the fill plug910, plug seals 912 and core pin seal 942 in one piece. Core pin 940 maybe made of stainless steel, PEEK, ceramic or other relatively rigidbiocompatible material, while push button 950 may be made of COP,Delrin, polycarbonate, or the like.

Another exemplary embodiment of primary packaging at the fill plug isshown in FIGS. 17A-17E. In this example, fill plug 1010 and core pin1040 of fill plug seal assembly 1004 seal the reservoir while in storageand/or before dispensing. More specifically, fill plug 1010 includes aninner surface that defines an inlet lumen 1049, and core pin 1040 ispositioned within the inlet lumen. A fill plug outlet lumen 1064connects inlet lumen 949 to reservoir connection 1039. When core pin1040 is in the storage or pre-dispensing position (i.e., the first (or“seal”) position where the button 1050 has not be pushed yet), the coreend seal 1046 engages the inner surface of fill plug 1010 to seal thepassage from reservoir 936 through fill plug 1010 to reservoirconnection 939 (which is defined by lumens 1049 and 1064), as best seenin FIG. 17C. When device 100/100 a is ready for use, and the patientwants medicament to be dispensed from reservoir 936, push button 1050should be pressed down until it is fully seated in fill plug 1010. Asbest seen in FIG. 17E, as button 1050 is pressed, core pin 1040 advancestowards reservoir 936 to a second (or “unseal”) position where core endseal 1046 disengages from the inner surface of fill plug 1010 thatdefines inlet lumen 1049, leaving a gap 1055 through which medicamentmay flow from reservoir 936, around core end seal 1046, through lumens1049 and 1064 of fill plug 1010, and through reservoir connection 939.Plug seals 1012 on the outer surface of fill plug 1010 preventmedicament from leaking out around the outside of fill plug 1010, whilecore pin seals 1042 prevent medicament from leaking through the fillplug 1010 and around the outside of core pin 1040 after core end seal1046 has been disengaged from fill plug 1010. As above, fill plug 1010,plug seals 1012, and core pin seals 1042 may be made of rubber or otherrelatively conformable sealing material, such as by injection molding;core pin 1040 may be made of COP, Delrin, polycarbonate or otherbiocompatible polymeric material; and push button 1050 may be made ofCOP, Delrin, polycarbonate, or the like. While FIGS. 17A-17E show corepin 1040 with a blunt end 1044, this exemplary embodiment and thedirectly preceding exemplary embodiment may be combined by adding a thinseal 980 to the end of reservoir 936, and a sharp tip like sharp tip 944to blunt end 1044, so that pushing button 1050 punctures thin seal 940as well as creating gap 1055 around the core end seal 1046.

To prevent accidental depression of button 1050 (or button 950), abutton guard may be inserted between button 1050/950 and fill plug1010/910. An exemplary button guard 1160 is shown in FIGS. 18A-18C. Whenbutton guard 1160 is in place, it is not possible to press button950/1050 to move core pin 940/1040 to break the seal 980/1046 to allowfluid to flow through fill plug 910/1010. Button guard 1160 may be madeof COP, Delrin, polycarbonate or other similar polymeric material.

Various methodologies and systems are presented here in the context ofthe exemplary structures described in the preceding sections, andillustrated in the various figures, for the purpose of explanation only.Although the present methodologies and systems may employ the structuresdescribed above, they are not limited thereto. Additionally, embodimentsof the present inventions may incorporate any one, combinations of lessthan all, or all of the methodologies or devices referenced above.

Although the inventions disclosed herein have been described in terms ofthe preferred embodiments above, numerous modifications and/or additionsto the above-described preferred embodiments would be readily apparentto one skilled in the art. By way of example, but not limitation, thepresent medicament sealing assemblies may be incorporated into fullydisposable infusion pumps. It is intended that the scope of the presentinventions extends to all such modifications and/or additions and thatthe scope of the present inventions is limited solely by the claims setforth below or later added.

Finally, with respect to terminology that may be used herein, whether inthe description or the claims, the following should be noted. The terms“comprising,” “including,” “carrying,” “having,” “containing,”“involving,” and the like are open-ended and mean “including but notlimited to.” Ordinal terms such as “first”, “second”, “third,” do not,in and of themselves, connote any priority, precedence, or order of oneelement over another or temporal order in which steps of a method areperformed. Instead, such terms are merely labels to distinguish oneelement having a certain name from another element having a same name(but for the ordinal term) to distinguish the elements. “And/or” meansthat the listed items are alternatives, but the alternatives alsoinclude any combination of the listed items. The terms “approximately,”“about,” “substantially” and “generally” allow for a certain amount ofvariation from any exact dimensions, measurements, and arrangements, andshould be understood within the context of the description and operationof the invention as disclosed herein. Terms such as “top,” “bottom,”“above,” and “below” are terms of convenience that denote the spatialrelationships of parts relative to each other rather than to anyspecific spatial or gravitational orientation. Thus, the terms areintended to encompass an assembly of component parts regardless ofwhether the assembly is oriented in the particular orientation shown inthe drawings and described in the specification, upside down from thatorientation, or any other rotational variation therefrom.

We claim:
 1. An apparatus, comprising: a medicament reservoir; areservoir outlet in fluid communication with the medicament reservoir;and a trocar seal assembly integrated into the apparatus, the trocarseal assembly associated with the reservoir outlet and including acannula and a trocar with a rod and a sharp end that is movable relativeto the reservoir outlet, the trocar being configured to preventmedicament from flowing through the reservoir outlet to the cannula whenthe trocar is in a first position and to permit medicament flow throughthe reservoir outlet to the cannula in response to the trocar beingmoved from the first position.
 2. An apparatus as claimed in claim 1,wherein the trocar seal assembly includes a drum having a drum inlet influid communication with the reservoir outlet and a drum outlet; and aportion of the trocar is located within the drum outlet when in thefirst position.
 3. An apparatus as claimed in claim 2, wherein the drumis located within the reservoir outlet.
 4. An apparatus as claimed inclaim 2, wherein the trocar rod defines an outer surface; and the drumoutlet comprises a longitudinally extending drum outlet lumen includingat least one seal that engages the outer surface of the trocar rod whenthe trocar is in the first position.
 5. An apparatus as claimed in claim1, wherein the trocar seal assembly includes a septum.
 6. An apparatusas claimed in claim 5, wherein the trocar seal assembly includes a drumhaving a drum inlet in fluid communication with the reservoir outlet anda drum outlet; and the septum is either adjacent to the drum or integralwith the drum.
 7. An apparatus as claimed in claim 1, wherein the trocaris removable from the remainder of the trocar seal assembly.
 8. Anapparatus as claimed in claim 1, wherein the trocar seal assemblycomprises a drum having a drum inlet in fluid communication with thereservoir outlet and a drum outlet; and the trocar seal assemblycomprises a cannula insert within the cannula, wherein the cannulainsert is configured to seal the cannula to the reservoir outlet and thecannula insert is positioned between the cannula and the drum outlet. 9.An apparatus comprising: a medicament reservoir; a reservoir outlet influid communication with the medicament reservoir; and a trocar sealassembly integrated into the apparatus, the trocar seal assemblyassociated with the reservoir outlet and including a trocar with a rodand a sharp end that is movable relative to the reservoir outlet,configured to prevent medicament from flowing through the reservoiroutlet when the trocar is in a first position and to permit medicamentflow through the reservoir outlet in response to the trocar being movedfrom the first position, wherein the trocar seal assembly includes adrum having a drum inlet in fluid communication with the reservoiroutlet and a drum outlet; a portion of the trocar is located within thedrum outlet when in the first position; the trocar seal assemblyincludes a cannula, with an outer surface and a cannula inlet, that ismovable relative to the reservoir outlet; at least a portion of thetrocar is located within the cannula; the drum outlet comprises alongitudinally extending drum outlet lumen including at least one sealthat engages the outer surface of the cannula; and the cannula inlet isnot in fluid communication with the drum inlet when the trocar is in thefirst position.
 10. An apparatus as claimed in claim 9, wherein thecannula is movable with the trocar to a position where the cannula inletis in fluid communication with the drum inlet.
 11. An apparatus asclaimed in claim 9, wherein the at least one seal is on an inner surfaceof the drum outlet.
 12. An infusion pump, comprising: an apparatus asclaimed in claim 1; and a fluid displacement device that drivesmedicament from the medicament reservoir.
 13. An infusion pump asclaimed in claim 12, wherein the fluid displacement device includes aplunger within the reservoir and a drive mechanism that drives theplunger.
 14. An infusion pump as claimed in claim 13, wherein the drivemechanism includes a motor.